Characteristics of patients, according to treatment arm
| Characteristic . | Study arm . | |
|---|---|---|
| Prednisone (N = 145) . | CSP plus prednisone (N = 142) . | |
| Patient age at transplantation, median y (range) | 30.0 (2.3-56.5) | 30.8 (0.9-57.1) |
| Disease risk, N (%)* | ||
| Low | 61 (42) | 54 (38) |
| Intermediate | 46 (32) | 50 (35) |
| High | 38 (26) | 38 (27) |
| Donor type, N (%) | ||
| HLA-identical sibling | 99 (68) | 95 (67) |
| HLA-mismatched relative | 32 (22) | 28 (20) |
| Unrelated | 14 (10) | 19 (13) |
| Patient/donor sex, N (%) | ||
| Female/female | 30 (21) | 43 (30) |
| Female/male | 22 (15) | 24 (17) |
| Male/female | 53 (37) | 35 (25) |
| Male/male | 40 (28) | 40 (28) |
| Prophylaxis for acute GVHD, N (%) | ||
| Methotrexate | 9 (6) | 15 (11) |
| Cyclosporine ± glucocorticoids | 10 (7) | 20 (14) |
| Methotrexate plus cyclosporine | 122 (84) | 106 (75) |
| Other† | 4 (3) | 1 (1) |
| Onset type, N (%)‡ | ||
| De novo | 51 (35) | 44 (31) |
| Quiescent | 65 (45) | 82 (58) |
| Progressive | 29 (20) | 16 (11) |
| Immunosuppressive medications at enrollment, N (%) | ||
| Cyclosporine alone | 56 (39) | 38 (27) |
| Cyclosporine plus prednisone | 23 (16) | 31 (22) |
| Prednisone | 12 (8) | 9 (6) |
| None | 54 (37) | 64 (45) |
| Interval from transplantation to onset of chronic GVHD, N (%) | ||
| < 100 days | 41 (28) | 33 (23) |
| ≥ 100 days | 104 (72) | 109 (77) |
| Characteristic . | Study arm . | |
|---|---|---|
| Prednisone (N = 145) . | CSP plus prednisone (N = 142) . | |
| Patient age at transplantation, median y (range) | 30.0 (2.3-56.5) | 30.8 (0.9-57.1) |
| Disease risk, N (%)* | ||
| Low | 61 (42) | 54 (38) |
| Intermediate | 46 (32) | 50 (35) |
| High | 38 (26) | 38 (27) |
| Donor type, N (%) | ||
| HLA-identical sibling | 99 (68) | 95 (67) |
| HLA-mismatched relative | 32 (22) | 28 (20) |
| Unrelated | 14 (10) | 19 (13) |
| Patient/donor sex, N (%) | ||
| Female/female | 30 (21) | 43 (30) |
| Female/male | 22 (15) | 24 (17) |
| Male/female | 53 (37) | 35 (25) |
| Male/male | 40 (28) | 40 (28) |
| Prophylaxis for acute GVHD, N (%) | ||
| Methotrexate | 9 (6) | 15 (11) |
| Cyclosporine ± glucocorticoids | 10 (7) | 20 (14) |
| Methotrexate plus cyclosporine | 122 (84) | 106 (75) |
| Other† | 4 (3) | 1 (1) |
| Onset type, N (%)‡ | ||
| De novo | 51 (35) | 44 (31) |
| Quiescent | 65 (45) | 82 (58) |
| Progressive | 29 (20) | 16 (11) |
| Immunosuppressive medications at enrollment, N (%) | ||
| Cyclosporine alone | 56 (39) | 38 (27) |
| Cyclosporine plus prednisone | 23 (16) | 31 (22) |
| Prednisone | 12 (8) | 9 (6) |
| None | 54 (37) | 64 (45) |
| Interval from transplantation to onset of chronic GVHD, N (%) | ||
| < 100 days | 41 (28) | 33 (23) |
| ≥ 100 days | 104 (72) | 109 (77) |
Low-risk diseases included chronic myeloid leukemia in chronic phase, refractory anemia, aplastic anemia, and Blackfan-Diamond syndrome. Intermediate-risk diseases included chronic myeloid leukemia in accelerated phase or in chronic phase after blast phase, acute leukemia or lymphoma in remission, refractory anemia with excess blasts, chronic lymphocytic leukemia, and paroxysmal nocturnal hemoglobinuria. High-risk diseases included chronic myeloid leukemia in blast phase, juvenile chronic myeloid leukemia, acute leukemia or lymphoma in relapse, refractory anemia with excess blasts in transformation, and myeloma.
Two patients in the prednisone arm underwent T cell–depleted second marrow transplantation with no posttransplantation immunosuppression, and 2 underwent unmodified second marrow transplantation with glucocorticoids or no posttransplantation immunosuppression for the prevention of acute GVHD. One patient in the CSP plus prednisone arm underwent a second marrow transplantation, with glucocorticoids and ATG administered for the prevention of acute GVHD.
De novo onset indicates the absence of prior acute GVHD. Quiescent onset indicates a history of acute GVHD that resolved before the onset of chronic GVHD. Progressive onset indicates a history of acute GVHD that did not resolve before the onset of chronic GVHD.